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NCT05338320 Clinical Trial

Postoperative Analgesia in Patients Undergoing Elective Lumbar Fusion Operations Under General Anesthesia

Post Operative Pain Clinical Trial

Official title:
A Randomized Controlled Trial for Postoperative Analgesia in Patients Undergoing Elective Lumbar Fusion Operations Under General Anesthesia: Ultrasound Guided Erector Spinae Plane Block Versus Intrathecal Morphine

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05338320
Other study ID # FMASU MD 102/2022
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date May 10, 2022
Est. completion date July 31, 2024

Study information
Verified date June 2024
Source Ain Shams University
Contact Ibrahim Mamdouh Esmat
Phone 01001241928
Email ibrahim_mamdouh@med.asu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It was proven that intrathecal opioids are considered as an effective means of pain control in several major surgical interventions including spine surgeries. Intrathecal morphine added to a spinal anesthesia reduces acute pain after spine surgeries but has side effects, including dose dependent respiratory depression, nausea, vomiting, pruritus, and sedation. Ultrasound guided Erector Spinae Plane Block (ESPB) was first described in 2016.Recent case reports suggest a positive effect of ultrasound guided ESPB on pain for multiple indications including lumbar spine fusion and scoliosis surgery, with a very low risk of complications as there are no structures in close proximity at risk of needle injury.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years to 55 Years
Eligibility Inclusion Criteria: - Body mass index (BMI) 25 to 35 kg/m². - American Society of Anesthesiologist (ASA) physical status I or II. Exclusion Criteria: - patient's refusal - Altered mental status - Known allergy to study drugs (bupivacaine or morphine) - Local infection at site of puncture. - Known case with any pulmonary disease - Known case with Obstructive sleep apnea (OSA) - Coagulopathy and /or thrombocytopenia - Chronic pain - Severe hepatic or kidney impairment

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Ultrasound Guided Erector Spinae Plane Block
General anesthesia and Ultrasound Guided Erector Spinae Plane Block
Drug:
• Intrathecal morphine
General anesthesia and intrathecal morphine
Other:
• General anesthesia using intravenous fentanyl (1µg/kg)
General anesthesia using intravenous fentanyl (1µg/kg)

Locations
Country Name City State
Egypt Ain-Shams University Hospitals Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to first requested rescue analgesia (Minutes). Time to first requested rescue analgesia (Minutes). First 24 hours after surgery.
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